Review methods Included studies were randomised controlled trials comparing screening by prostate specific antigen with or without digital rectal examination versus no screening. Data abstraction and assessment of methodological quality with the GRADE approach was assessed by two independent reviewers and verified by the primary investigator. Mantel-Haenszel and inverse variance estimates were calculated and pooled under a random effects model expressing data as relative risks and 95% confidence intervals.

Results Six randomised controlled trials with a total of 387 286 participants that met inclusion criteria were analysed. Screening was associated with an increased probability of receiving a diagnosis of prostate cancer (relative risk 1.46, 95% confidence interval 1.21 to 1.77; P<0.001) and stage I prostate cancer (1.95, 1.22 to 3.13; P=0.005). There was no significant effect of screening on death from prostate cancer (0.88, 0.71 to 1.09; P=0.25) or overall mortality (0.99, 0.97 to 1.01; P=0.44). All trials had one or more substantial methodological limitations. None provided data on the effects of screening on participants’ quality of life. Little information was provided about potential harms associated with screening.

Conclusions The existing evidence from randomised controlled trials does not support the routine use of screening for prostate cancer with prostate specific antigen with or without digital rectal examination.

Footnotes

We thank Shahnaz Sultan and Robbie Eller for proof reading the manuscript.

Contributors: MD and PD were responsible for study concept, study design, data collection, data interpretation, and preparation of the manuscript. RJB was responsible for study concept, data interpretation and preparation of the manuscript. MMN was responsible for data collection and data analysis. TLS was responsible for data collection and preparation of the manuscript. JV was responsible for data interpretation and preparation of the manuscript. BD was responsible for study concept, study design, data interpretation, and preparation of the manuscript. PD is guarantor.

Funding: This study was funded by the Department of Urology, University of Florida, and the Dennis W Jahnigen Career Development Scholars Award through the American Geriatrics Society. The funders had no role in study design, the collection, analysis, and interpretation of data, the writing of the report, or the decision to submit the article for publication.

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any institution for the submitted work; no financial relationships with any institutions that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

Ethical approval: Not required.

Data sharing: The GRADE evidence profile is available on request from the authors.